Electro-stimulation systems and methods for rehabilitation and treatment of sexual disorders

Abstract

An implantable stimulation system having an implantable stimulation unit coupled to a programmable controller, a stimulation circuit and an array of electrodes disposed on a pair of flexible paddles is provided for selectively stimulating at least one cavernous nerve. The programmable controller is pre-programmed to run an excitation electrode routine that selectively scans the electrode arrays on the paddles with a series of directional current flows, in at least two directions and within at least two regions, to optimize electrode selection for use in stimulating the cavernous nerve. The implantable stimulation system may be programmed to run a first stimulation pulse sequence corresponding to a first mode for invoking a rapid erectile response, and optionally, a second nerve rehabilitation stimulation mode selected to rehabilitate neural transmission in a cavernous nerve, and/or a third penile rehabilitation mode selected to reduce penile fibrosis. Methods of operating the system also are provided.

What is claimed is: 
     
       1. An implantable system for treating erectile dysfunction, the system comprising:
 a flexible paddle having an array of electrodes comprising at least two rows of electrodes and at least two columns of electrodes; and 
 a programmable controller comprising a stimulation circuit, a microprocessor and a memory, the stimulation circuit operatively coupled to the array, the microprocessor configured to execute programmed instructions stored in the memory to:
 cause the stimulation circuit to selectively activate a first pair of electrodes of the array to create a first current flow therebetween in a first direction, the first current flow configured to stimulate a cavernous nerve to elicit a first erectile response; 
 cause the stimulation circuit to selectively activate a second pair of electrodes of the array to create a second current flow therebetween in a second direction, the second direction different than, and oblique to, the first direction, the second current flow configured to stimulate the cavernous nerve to elicit a second erectile response; 
 identify either the first erectile response or the second erectile response as a first preferred erectile response; and 
 store an identity of either the first direction or the second direction as a preferred current direction for subsequent stimulation of the cavernous nerve. 
 
 
     
     
       2. The implantable system of  claim 1 , wherein the programmed instructions identify either the first erectile response or the second erectile response as the first preferred erectile response responsive to input generated by a sensor system associated with the programmable controller. 
     
     
       3. The implantable system of  claim 1 , wherein the programmed instructions identify either the first erectile response or the second erectile response as the first preferred erectile response responsive to input provided by an external patient controller or an external physician controller. 
     
     
       4. The implantable system of  claim 1 , wherein the array of electrodes comprises a first region and a second region and the microprocessor further is configured to execute programmed instructions stored in the memory to:
 cause the stimulation circuit to selectively activate electrodes in the first region with the preferred current direction to generate a third erectile response; 
 cause the stimulation circuit to selectively activate electrodes in the second region with the preferred current direction to generate a fourth erectile response; 
 identify either the third erectile response or the fourth erectile response as a second preferred erectile response; and 
 store an identity of either the first region or the second region as a preferred region. 
 
     
     
       5. The implantable system of  claim 4 , wherein the programmed instructions identify either the third erectile response or the fourth erectile response as a second preferred erectile response responsive to input generated by a sensor system associated with the programmable controller. 
     
     
       6. The implantable system of  claim 4 , wherein the programmed instructions identify either the third erectile response or the fourth erectile response as a second preferred erectile response responsive to input provided by an external patient controller or an external physician controller. 
     
     
       7. The implantable system of  claim 4 , wherein the microprocessor further is configured to execute programmed instructions stored in the memory to:
 cause the stimulation circuit to sequentially activate subsets of electrodes within the preferred region with the preferred current direction to elicit a series of erectile responses; 
 identify a favorable erectile response from amongst the series of erectile responses; and 
 store an identity of at least one subset of electrodes within the preferred region as a preferred set of excitation electrodes for subsequent stimulation of the cavernous nerve. 
 
     
     
       8. The implantable system of  claim 7 , wherein the programmed instructions identify the favorable erectile response from amongst the series of erectile responses responsive to input generated by a sensor system associated with the programmable controller. 
     
     
       9. The implantable system of  claim 7 , wherein the programmed instructions identify the favorable erectile response from amongst the series of erectile responses responsive to input provided by an external patient controller or an external physician controller. 
     
     
       10. The implantable system of  claim 7 , wherein the microprocessor further is configured to execute programmed instructions stored in the memory to:
 cause the stimulation circuit to selectively activate the preferred set of excitation electrodes in the preferred current direction with a series of stimulation parameters to elicit a further series of erectile responses; 
 identify an optimal response from amongst the series of further erectile responses; and 
 store as preferred stimulation parameters the stimulation parameters that elicit the optimal response. 
 
     
     
       11. The implantable system of  claim 10 , wherein the programmed instructions identify the optimal response from amongst the series of further erectile responses responsive to input generated by a sensor system associated with the programmable controller. 
     
     
       12. The implantable system of  claim 10 , wherein the programmed instructions identify the optimal response from amongst the series of further erectile responses responsive to input provided by an external patient controller or an external physician controller. 
     
     
       13. The implantable system of  claim 10 , wherein the programmed instructions that store the preferred stimulation parameters store stimulation parameters that elicit a rapid erectile response. 
     
     
       14. The implantable system of  claim 10 , wherein the programmed instructions that store the preferred stimulation parameters store stimulation parameters that rehabilitate neural transmission via the cavernous nerve. 
     
     
       15. The implantable system to  claim 10 , wherein the programmed instructions that determine the preferred current direction, the preferred region, the preferred set of excitation electrodes and the preferred stimulation parameters are configured to be periodically executed after the implantable system is implanted responsive to a command from an external patient controller or an external physician controller. 
     
     
       16. The implantable system of  claim 10 , wherein the programmable controller is configured to adjust the preferred stimulation parameters using at least one of machine learning or artificial intelligence. 
     
     
       17. The implantable system of  claim 13 , wherein the programmable controller is configured to activate the stimulation circuit to apply the stimulation parameters that elicit a rapid erectile response responsive to a command received from an external patient controller. 
     
     
       18. The implantable system of  claim 14 , wherein the programmable controller is configured to automatically activate the stimulation circuit to apply the stimulation parameters that rehabilitate neural transmission at least once per day. 
     
     
       19. The implantable system of  claim 1 , wherein the flexible paddle is configured to be implanted at the pelvic plexus via a laparoscopic surgery. 
     
     
       20. The implantable system of  claim 1 , wherein the flexible paddle has a hemispherical shape. 
     
     
       21. A method for treating erectile dysfunction, the method comprising:
 placing a flexible paddle at a first position adjacent to a pelvic plexus and near a cavernous nerve, the flexible paddle having an array of electrodes comprising at least two rows of electrodes and at least two columns of electrodes; 
 selectively activating with a programmable controller a first pair of electrodes of the array to stimulate the cavernous nerve with current flow in a first direction that elicits a first erectile response; 
 selectively activating with the programmable controller a second pair of electrodes of the array to stimulate the cavernous nerve with current flow in a second direction, the second direction different than, and oblique to, the first direction, that elicits a second erectile response; 
 comparing the first erectile response and the second erectile response to determine a preferred erectile response; and 
 storing in the programmable controller either the first direction or the second direction as a preferred current direction for application of further stimulation with the programmable controller.